Method for lymphotropic treatment of lymphoedema

Abstract

The invention relates to clinical medicine, and more particularly to lymphology, surgery, plastic surgery and oncology, for treating lymphatic swelling in the case of primary or secondary lymphoedema in adults and children, inter alia accompanied by infectious complications, and even more particularly relates to methods for treating lymphoedema and to the use of accessible drugs in the treatment of lymphatic swelling at any stage and in any location. The claimed method for the lymphotropic treatment of lymphoedema involves consecutively preparing an injectable drug composition A containing an adrenergic alpha-1 receptor agonist and a glucocorticoid, administering same by lymphotropic interstitial injection by puncturing the interstitial tissue of the lymphatic region of interest and introducing the drug composition, preparing an injectable drug composition B containing a cholinesterase inhibitor, administering same by lymphotropic interstitial injection by puncturing the interstitial tissue of the lymphatic region of interest and introducing the drug composition, and also, if necessary, preparing an injectable drug composition C containing bovhyaluronidase azoximer, and administering same by interstitial injection by puncturing the interstitial tissue of the lymphatic region of interest. The technical result consists in improving the drainage of free fluid from the tissues and reducing limb swelling in the case of lymphoedema.

Description

[0001] LYMPHOTROPIC TREATMENT OF LYMPHEDEMA

[0002] AREA OF TECHNOLOGY

[0003] The invention relates to clinical medicine, namely to lymphology, surgery, plastic surgery, oncology, for the treatment of lymphatic edema, primary and secondary lymphedema, in adults and children, including those accompanied by infectious complications, namely to methods for treating lymphedema and the use of available drugs in the treatment of any stage and localization of lymphatic edema.

[0004] PRIOR ART

[0005] Lymphedema is a chronic, progressive disease of the lymphatic system. It impairs the drainage and detoxification function of the lymphatic system, leading to impaired drainage of free fluid from the tissues of the extremities, resulting in high-protein edema. As a result, limb size increases as the disease progresses, leading to pain, limited range of motion, and a significant deterioration in quality of life.

[0006] Pathogenic causes of lymphatic system damage include: developmental abnormalities of the lymphatic system, manifested at birth, during the first year of life, or with age due to provoking factors; damage to the structures of the lymphatic system as a result of trauma, another disease, or surgery, for example, during lymph node dissection as part of cancer treatment.

[0007] Swelling due to lymphedema provokes the development of neuropathy with the following symptoms: pain, numbness of the limb, tingling, disorder of the peripheral nervous regulation of the vascular tone of the lymphangions, which in turn aggravates the course of lymphatic edema.

[0008] Lymphedema is caused by ineffective fluid removal by the lymphatic system, leading to fluid accumulation and subsequent swelling. This process contributes to tissue inflammation due to several factors: the accumulation of proteins and metabolic waste products, which stimulate inflammatory responses; mechanical tissue irritation due to persistent swelling; and an increased risk of infection due to lymphatic stagnation, which also contributes to inflammation. With prolonged swelling, the subcutaneous tissue becomes fibrotic, dense, and puts pressure on the lymphatic capillaries and vessels, which can lead to their hardening and complete dysfunction.

[0009] According to the consensus of the international community of lymphologists, there are approaches to surgical and conservative treatment of lymphedema.

[0010] Surgical correction methods include lymphovenous anastomoses, lymph node grafting, and liposuction. Lymphovenous anastomoses and lymph node grafting are only suitable in the early stages of the disease. A disadvantage of liposuction is that it is a palliative procedure intended solely for radical limb circumference reduction and does not address the underlying pathogenesis of the disease.

[0011] Conservative treatments for lymphedema include medications such as diuretics, benzopyrene medications, and antibiotics. A disadvantage of this approach is its nonspecificity: it has no direct effect on the lymphatic system.

[0012] There are data on the activity of the drug Mezaton (phenylephrine hydrochloride) in stimulating the contractility of lymphatic collectors in animal experiments (Orlov RS, Borisova RI. Contraction of the lymphatic vessels, their regulation and functional role / / Vesti. USSR Academy of Medical Sciences. - 1982. - No. 7. - P. 75-83. [Orlov RS, Borisova RP. Contraction of the lymphatic vessels, their regulation and functional role. West. USSR Academy of Medical Sciences. 1982; 7:75-83.]).

[0013] The instructions for the sympathomimetic drug Mezaton are known. It is used as an alpha-1 adrenergic agonist to facilitate arteriolar constriction and increase blood pressure. The prior art does not disclose the use of Mezaton for the treatment of lymphedema in humans, nor its use via lymphotropic administration.

[0014] The instructions for Neuromidin (ipidcarine), a cholinesterase inhibitor (anticholinesterase) drug used to treat peripheral nervous system disorders, are well-known. However, the instructions do not recommend use for lymphedema, nor does it indicate that the drug is administered lymphotropically.

[0015] The instructions for the glucocorticosteroid drug Dexamethasone are known. At doses of 4 mg, it is used as an anti-inflammatory, anti-allergic, and immunosuppressant agent. The prior art does not disclose the use of Dexamethasone to reduce tissue inflammation in lymphedema in humans, nor the use of Dexamethasone via lymphotropic administration for lymphedema.

[0016] The instructions for the drug Longidaza (active ingredient bovhyaluronidase azoximer) are known. It belongs to the enzyme group and is used at a dose of 3000 IU once every 3 days, including for keloids, hypertrophic scars, and developing scars. The prior art does not know of any use of Longidaza for the treatment of lymphedema, including subcutaneous fibrosis associated with lymphedema.

[0017] Lymphotropic administration of drugs is effective and allows for a reduction in the dosage of drugs by providing a targeted effect on the lesion (Borodin Yu.I. Institute of Lymphology and Problems of Lymphology / / Bulletin of the Siberian Branch of the Russian Academy of Medical Sciences. - 2001. - No. 4. - P. 5-11).

[0018] The prior art does not contain any sources of information on the lymphotropic combined use of sympathomimetic drugs (Mezaton) together with glucocorticosteroids (Dexamethasone), as well as cholinesterase inhibitors (Neuromidin), for the treatment of lymphedema.

[0019] A method for indirectly diagnosing lymphangion motility in lower extremity lymphedema (RU 2407434, published 27.12.2010, MIC: A61B 5 / 107) involves administering an alpha1-adrenergic agonist lymphotropically to indirectly diagnose the ability of lymphangions to contract. A disadvantage of this method is the use of a 5-10 mg dose of Mezaton combined with saline, which limits its use in patients with arterial hypertension, as the direct effect of the drug, according to the instructions, is to increase blood pressure. A second disadvantage is the need to administer the drug to the site of edema, which limits therapy in patients with pre-existing infectious complications.

[0020] ESSENCE OF THE INVENTION

[0021] The claimed invention is aimed at solving the following technical problems:

[0022] 1. Use of available medications in the treatment of any stage and localization of lymphedema.

[0023] 2. Reduction of the inflammatory reaction in the area of ​​swelling, which complicates the course of the disease.

[0024] 3. Reduction of fibrosis of the proliferating subcutaneous tissue, which increases the volume of the limb and creates unfavorable conditions for the drainage of edema fluid.

[0025] 4. Strengthening the work of lymphatic collectors to facilitate the drainage of fluid from the tissue.

[0026] 5. Reduction in the size of the swollen limb.

[0027] 6. Reduction of the severity of pain and other symptoms of neuropathy in lymphedema.

[0028] These objectives are achieved by achieving a technical result, which consists of improving the drainage of free fluid from tissues and reducing swelling of the extremities in lymphedema.

[0029] An additional technical result is the creation of long-term target concentrations of the medicinal mixture in the affected lymphatic region through lymphotropic interstitial administration to the area providing access to the target lymphatic region—the compromised segment of the lymphatic system. This allows for a reduction in the effective dosage of the drugs used and avoidance of side effects.

[0030] The technical result is achieved by implementing the claimed method for lymphotropic treatment of lymphedema, in which an injectable medicinal composition A is sequentially prepared, containing an Alpha1-adrenergic agonist and a glucocorticosteroid, its lymphotropic interstitial injection is carried out by puncturing the interstitium of the lymphatic region in question and introducing it, an injectable medicinal composition B is prepared, containing a cholinesterase inhibitor, its lymphotropic interstitial injection is carried out by puncturing the interstitium of the lymphatic region in question and introducing it; an injectable medicinal composition B is prepared, containing bovgiauloronidase azoximer, its interstitial injection is carried out by puncturing the interstitium of the lymphatic region in question.

[0031] The administration of medicinal composition A is carried out using a syringe dispenser for 30-40 minutes, the administration of medicinal composition B is carried out manually, without using a dispenser, with a needle with a maximum size of 0.5*25 mm 25 G for 2-5 minutes, the administration of medicinal composition C is carried out manually, without using a dispenser.

[0032] Injections of medicinal composition A and medicinal composition B are administered once daily for a course of 9 to 15 days. Injections of medicinal composition B are administered starting on the third day of treatment and are administered a total of 3 to 5 times during the course of treatment. The duration of the course of treatment is determined by the number of injections of medicinal composition A.

[0033] Injectable medicinal composition A, containing a sympathomimetic drug (from the Alpha-adrenergic class, for example, Mezaton, phenylephrine) and a glucocorticosteroid (for example, Dexamethasone), is administered into a specific lymphatic region (LT 10, LT 14, LT 15) in order to activate the lymphatic vessels and enhance their contractile activity.

[0034] Injectable medicinal composition B, containing a drug of the anticholinesterase class (Neuromidin, ipidacrine), is administered into a lymphatic region determined for composition B (LT 16, LT 17) for the purpose of treating neuropathy that accompanies lymphedema, which relieves the patient from discomfort and helps the lymphatic vessels to contract, evacuating fluid from the tissues.

[0035] Injectable medicinal composition B, containing a drug of the enzyme class (Longiadase, with the active substance bovgiauloronidase azoximer), is administered into a lymphatic region determined for composition B (LT10, LT14, LT15) in order to reduce subcutaneous tissue fibrosis, which facilitates lymphatic drainage.

[0036] For an injectable medicinal composition A containing an alpha1-adrenergic agonist, a mixture of medicinal preparations is prepared ex tempore, including up to 2 mg of a drug of the Alpha-adrenergic agonist class, 2 mg of the drug Dexamethasone and up to 10 ml of a physiological solution of 0.9% NaCl, while as a drug from the Alpha-adrenergic agonist class, the medicinal composition may contain a drug in which the active substance is phenylephrine.

[0037] The use of alpha-adrenergic agonists (phenylephrine, Mezaton) to reduce edema has not been described and is new. However, their use at the prescribed dosage of 5-10 mg leads to an increase in blood pressure (BP) in patients and poses a risk of cardiovascular complications. In the claimed invention, the effective dosage of alpha-1-adrenergic agonists is up to 2 mg, which is sufficient to increase the contractility of lymphatic vessels in the area of ​​edema, but does not lead to an increase in blood pressure due to lymphotropic administration.

[0038] The actual dosage of alpha-1-adrenergic agonist used in the claimed method is 1.5-3 times less than the dose prescribed in the drug's instructions. For example, according to the instructions for Mezaton, the dosage for subcutaneous administration is 0.3-1 ml of a 1% solution, which yields 3-10 mg of the active ingredient. In the claimed method, when Mezaton is injected into specific areas, the dosage is 1-2 mg. This reduction in dosage results in a therapeutic effect by improving fluid drainage from edematous tissues, but does not increase the patient's blood pressure.

[0039] Dexamethasone reduces the inflammatory response in lymphedema by inhibiting phospholipase A2 to reduce the production of prostaglandins and leukotrienes, which reduces inflammation. It also reduces blood vessel permeability, thereby reducing the leakage of fluid and proteins into tissues and, consequently, swelling. Furthermore, dexamethasone suppresses the immune system, which may be important in the autoimmune components of lymphedema. All this contributes to a reduction in swelling and the size of the affected limb.

[0040] When implementing the method in terms of using an injectable medicinal composition A, a medicinal composition is prepared, a lymphotropic interstitial injection of the prepared medicinal composition is carried out by puncturing the interstitium of the interested lymphatic region and introducing the medicinal composition, the introduction of medicinal composition A is carried out using a syringe dispenser for 30-40 minutes.

[0041] The lymphatic regions for injection of medicinal composition A are LT 10, LT 14, LT 15.

[0042] In the treatment of lymphedema of the lower extremities, a puncture of the interstitium of the lymphatic region (puncture LT 10 Fig. 1) is performed by inserting a needle into the interstitium of the cellular space of the femoral triangle of the limb affected by edema (left or right), limited by the inguinal ligament 1, the sartorius muscle 2, and the adductor minor muscle 3.

[0043] In the treatment of lymphedema of the upper extremities, a puncture of the interstitium of the lymphatic region (puncture LT 14 Fig. 2) is performed by inserting a needle into the cellular space of the axillary cavity of the limb affected by edema (left or right), between the anterior wall formed by the large 4 and small 5 pectoral muscles, and the medial wall formed by the anterior serratus muscle 6.

[0044] In the treatment of lymphedema of the upper extremities with localization of edema at the level of the forearm and hand, puncture of the interstitium of the lymphatic region (puncture LT 15 Fig. 3) is performed by inserting a needle into the interstitium of the cellular space of the lower third of the medial groove of the shoulder, formed in front by the biceps brachii muscle 7, behind by the triceps brachii muscle 8, from the inside - by the coracobrachialis 9 and brachialis muscles 10.

[0045] For injection medicinal composition B containing a cholinesterase inhibitor, a mixture of medicinal preparations is prepared ex tempore, which includes up to 15 mg of a preparation from the cholinesterase inhibitor group and up to 4 ml of an anesthetic, wherein the medicinal composition may contain a preparation with the active substance ipidacrine (for example, Neuromidin, Ipidacrine, Axamon, etc.) as a preparation from the cholinesterase inhibitor group, and a preparation from the anesthetic group may contain the active substance Lidocaine (Lidocaine 2%, etc.) or procaine (Novocaine 0.5%, etc.).

[0046] A drug from the cholinesterase inhibitor group (ipidacrine, neuromedin, etc.) used in the treatment of lymphedema helps reduce the severity of neuropathy symptoms, such as pain, numbness of the limb, tingling, and disturbances in the peripheral nervous regulation of vascular tone of the lymphangions, which develops as a result of edema associated with lymphedema, which in turn worsens the course of lymphatic edema.

[0047] When implementing the method involving the use of injectable medicinal composition B, the medicinal composition is prepared and administered as a lymphotropic interstitial injection by puncturing the interstitium of the target lymphatic region and administering the medicinal composition. Medicinal composition B is administered manually, without the use of a dispenser, using a 25G needle with a maximum diameter of 0.5 x 25 mm for 2-5 minutes.

[0048] The lymphatic regions for injection of medicinal composition B are LT 16, LT 17.

[0049] In the treatment of lymphedema of the upper extremities, puncture of the interstitium of the lymphatic region (puncture LT 16 Fig. 4) is performed by inserting a needle into the cellular space of the interspinous space within the boundaries of C6-C7 or C7-TI1, piercing the supraspinous ligament 17.

[0050] In the treatment of lymphedema of the lower extremities, a puncture of the interstitium of the lymphatic region (puncture LT 17 Fig. 4) is performed by inserting a needle into the cellular space of the interspinous space within the boundaries of L4-L5 or L5-S1, piercing the spinous ligament 17.

[0051] For the injectable medicinal composition B containing an enzyme, a mixture of medicinal preparations is prepared ex tempore, which includes 1000 IU of a preparation from the enzyme group and up to 5 ml of an anesthetic, wherein the medicinal composition may contain a preparation with the active substance bovgiauloronidase azoximer (Longidaza) as a preparation from the enzyme group, and a preparation from the anesthetic group may contain Lidocaine (Lidocaine 2%, etc.) or procaine (Novocaine 0.5%, etc.).

[0052] A drug from the enzyme group (bovgiauloronidase azoximer, etc.) used in the treatment of lymphedema helps reduce the severity of soft tissue fibrosis in the edema area, which disrupts microcirculation in the tissues, which in turn worsens the course of lymphedema.

[0053] When implementing the method involving the use of injectable medicinal composition B, the medicinal composition is prepared and administered as a lymphotropic interstitial injection by puncturing the interstitium of the target lymphatic region and administering the medicinal composition. Medicinal composition B is administered manually, without the use of a dispenser, using a 25G needle with a maximum diameter of 0.5 x 25 mm for 2-5 minutes.

[0054] The lymphatic regions are the same regions as for the administration of medicinal composition A, i.e. regions LT 10, LT 14, LT 15.

[0055] The invention also relates to the use of a medicinal composition A containing a drug from the alpha-adrenergic agonist class and a glucocorticosteroid drug for the lymphotropic treatment of lymphedema by puncture of the interstitium of the lymphatic region in question and administration of the medicinal composition A, wherein the medicinal composition A is a composition prepared ex tempore.

[0056] The invention also relates to the use of medicinal composition B containing a cholinesterase inhibitor for lymphotropic treatment of lymphedema by puncture of the interstitium of the lymphatic region in question and administration of medicinal composition B, wherein medicinal composition B is a composition prepared ex tempore.

[0057] The invention also relates to the use of medicinal composition B containing an enzyme for the lymphotropic treatment of lymphedema by puncturing the interstitium of the lymphatic region in question and administering medicinal composition B, wherein medicinal composition B is a composition prepared ex tempore.

[0058] The invention also relates to the use of medicinal composition A, prepared ex tempore and containing a drug from the alpha-adrenergic agonist class and a glucocorticosteroid drug, in combination with medicinal composition B, prepared ex tempore and containing a cholinesterase inhibitor, and, if necessary, with medicinal composition C, prepared ex tempore and containing an enzyme, for the lymphotropic treatment of lymphedema by puncture of the interstitium of the lymphatic region in question and sequential administration of said medicinal composition A, medicinal composition B and medicinal composition C.

[0059] In one embodiment of the use, medicinal composition A contains a mixture of medicinal preparations including up to 2 mg of an Alpha-adrenergic agonist, 2 mg of Dexamethasone and up to 10 ml of a 0.9% NaCl physiological solution.

[0060] In one embodiment of the use, medicinal composition A as a drug from the Alpha-adrenergic agonist class contains a drug with the active substance phenylephrine.

[0061] In another embodiment of the use, the medicinal composition A as a drug from the Alpha-adrenergic agonist class contains a drug with the active substance midodrine.

[0062] In one embodiment, medicinal composition B additionally contains an anesthetic. In one embodiment, medicinal composition B contains a mixture of medicinal preparations comprising up to 15 mg of a cholinesterase inhibitor and up to 4 ml of an anesthetic.

[0063] In one embodiment of the use, medicinal composition B as a drug from the group of cholinesterase inhibitors contains a drug with the active substance ipidacrine.

[0064] In another embodiment of the use, medicinal composition B as a drug from the anesthetic group contains a drug with the active substance lidocaine or procaine.

[0065] In one embodiment of the use, the medicinal composition B additionally contains an anesthetic.

[0066] In one embodiment of the use, the medicinal composition B contains a mixture of medicinal preparations, which includes 1000 IU of a preparation from the enzyme group and up to 5 ml of an anesthetic, wherein the medicinal composition may contain a preparation with the active substance bovgiauloronidase azoximer as a preparation from the enzyme group, and the preparation from the anesthetic group may contain Lidocaine or procaine.The invention also relates to the use of medicinal composition A, containing a drug from the alpha-adrenergic agonist class and a glucocorticosteroid drug, in combination with medicinal composition B, containing a cholinesterase inhibitor, in a method for the lymphotropic treatment of lymphedema, in which said medicinal composition A is sequentially prepared, a lymphotropic interstitial injection of the prepared medicinal composition A is carried out by puncturing the interstitium of the interested lymphatic region and administering medicinal composition A, said medicinal composition B is prepared, a lymphotropic interstitial injection of medicinal composition B is carried out by puncturing the interstitium of the interested lymphatic region and administering medicinal composition B, wherein the administration of medicinal composition A is carried out using a syringe dispenser for 30-40 minutes., the introduction of medicinal composition B is carried out manually, with a needle with a maximum size of 0.5*25 mm 25 G for 2-5 minutes, injections are performed daily once a day, for a course of 9-18 days.

[0067] In one embodiment of the use in the method of lymphotropic treatment of lymphedema, after the completion of the administration of composition B, a medicinal composition B containing an enzyme is additionally prepared, a lymphotropic interstitial injection of medicinal composition B is carried out by puncturing the interstitium of the interested lymphatic region and introducing medicinal composition B, wherein the introduction of medicinal composition B is carried out manually, with a needle with a maximum size of 0.5*25 mm 25 G for 2-5 minutes, starting from the 3rd day of treatment and is performed a total of 3-5 times during the course of treatment.

[0068] The invention also relates to a combination of medicinal composition A, prepared ex tempore and containing a drug from the alpha-adrenergic agonist class and a glucocorticosteroid drug, medicinal composition B, prepared ex tempore and containing a cholinesterase inhibitor, and, if necessary, medicinal composition C, prepared ex tempore and containing an enzyme, for use in the lymphotropic treatment of lymphedema by puncture of the interstitium of the lymphatic region in question and sequential administration of said medicinal composition A, medicinal composition B and medicinal composition C.

[0069] The invention also relates to the use of a medicinal composition A containing a drug from the alpha-adrenergic agonist class and a glucocorticosteroid drug for the production of a medicinal product for the lymphotropic treatment of lymphedema by puncturing the interstitium of the lymphatic region in question and administering the medicinal composition A, wherein the medicinal composition A is a composition prepared ex tempore.

[0070] The invention also relates to the use of medicinal composition B containing a cholinesterase inhibitor for the production of a medicinal product for the lymphotropic treatment of lymphedema by puncturing the interstitium of the lymphatic region in question and administering medicinal composition B, wherein medicinal composition B is a composition prepared ex tempore.

[0071] The invention also relates to the use of a medicinal composition B containing an enzyme for the production of a medicinal product for the lymphotropic treatment of lymphedema by puncturing the interstitium of the lymphatic region in question and administering the medicinal composition B, wherein the medicinal composition B is a composition prepared ex tempore.

[0072] The invention is illustrated by the following figures. Fig. 1 shows the puncture site of the interstitium of the lymphatic region LT 10 for the administration of medicinal composition A and medicinal composition B in the treatment of lymphedema of the lower extremities.

[0073] Fig. 2 - demonstrates the puncture site of the interstitium of the lymphatic region LT 14 - for the introduction of medicinal composition A and medicinal composition B in the treatment of lymphedema of the upper extremities.

[0074] Fig. 3 - demonstrates the puncture site of the interstitium of the lymphatic region LT 15 - for the introduction of medicinal composition A and medicinal composition B in the treatment of lymphedema of the lower extremities.

[0075] Fig. 4 - demonstrates the puncture site of the interstitium of the lymphatic region LT 16 - for the introduction of medicinal composition B in the treatment of lymphedema of the upper extremities; LT 17 - the puncture site of the interstitium of the lymphatic region for the introduction of medicinal composition B in the treatment of lymphedema of the lower extremities.

[0076] BRIEF DESCRIPTION OF DRAWINGS

[0077] The following digital symbols are used on the figures:

[0078] 1. Inguinal ligament (1. Inguinalis)

[0079] 2. Sartorius muscle

[0080] 3. Small adductor muscle (m. adductor minimus)

[0081] 4. Pectoralis major muscle

[0082] 5. Pectoralis minor muscle

[0083] 6. Anterior serratus muscle (m. serratus anterior)

[0084] 7. Biceps brachii

[0085] 8. Triceps brachii

[0086] 9. Coracobrachialis muscle (m. coraco-brachialis)

[0087] 10. Shoulder muscle (m. brachialis)

[0088] 11. The sixth cervical vertebra C6 (vertebrae cervicales C6)

[0089] 12. The seventh cervical vertebra C7 (vertebrae cervicales C7

[0090] 13. The first thoracic vertebra Th1 (vertebrae thoracales Th1)

[0091] 14. The fourth lumbar vertebra L4 (vertebrae lumbales L4)

[0092] 15. The fifth lumbar vertebra L5 (vertebrae lumbales L5)

[0093] 16. The first sacral vertebra SI (vertebrae sacrales SI)

[0094] 17. Supraspinous ligament (ligg. supraspinalia) IMPLEMENTATION OF THE INVENTION

[0095] The invention is illustrated by the following examples of implementation.

[0096] Example No. 1: treatment of lymphedema of the upper limb.

[0097] Patient T, 63, female, complained of swelling, pain, and tension in the left upper extremity. She had been untreated for 15 years and sought medical attention. Upon presentation, her general condition was relatively satisfactory. Diagnosis: secondary lymphedema of the upper extremity, stage IIb, secondary to combination therapy for a malignant breast tumor.

[0098] Medicinal composition A, including Mezaton in a dosage of 1 mg, Dexamethasone 2 mg, 0.9% NaCl 8 ml was used in the form of a lymphotropic interstitial injection by puncture of LT 14 interstitium cellular space of the axillary cavity of the limb affected by edema of the lymphatic region with the introduction of the specified medicinal mixture with a syringe dispenser for 30 minutes.

[0099] The following day, the same medicinal mixture was administered via puncture of the LT 15 interstitium of the cellular space of the lower third of the medial sulcus of the arm. The administration routes were alternated every other day. The total course of treatment with medicinal composition A was 15 days.

[0100] Medicinal composition B, containing Neuromidin 15 mg (1 ml) and Novocaine 0.5% (4 ml), was used. Treatment was performed by puncture of the interstitium of the LT16 by inserting a needle into the cellular space of the interspinous space between C6 and C7, puncturing the supraspinous ligament, and then administering the medicinal mixture. The course of treatment with medicinal composition B was 10 days. No side effects were observed.

[0101] Medicinal composition B, containing Longidaza 1000 IU and 4 ml of 0.5% Novocaine, was used. Treatment was performed by interstitial puncture of the LT15, ​​which involves inserting a needle into the interstitium of the cellular space of the lower third of the medial humeral sulcus, followed by administration of the medicinal mixture. The course of treatment with medicinal composition B lasted 5 days, with administrations occurring on days 3, 6, 9, 12, and 15. No side effects were observed.

[0102] Compression hosiery was not used during the treatment.

[0103] The therapeutic effect was manifested in softening of tissues, reduction in the size of several arm circumferences (from 34 to 32 cm, from 22 to 21 cm), resolution of pain syndrome, and a decrease in the amount of free fluid determined in the arm according to the results of ultrasound morphometry.

[0104] Example No. 2: treatment of lymphedema of the lower limb.

[0105] Patient 3, 51, female. Complaints of swelling, hyperemia, tingling, pain, and a feeling of fullness in both legs. The swelling began in 2015. She sought medical attention in 2023. At the appointment, her general condition was satisfactory. Diagnosis: Stage III lower extremity lymphedema.

[0106] Medicinal composition A, containing Mezaton at a dosage of 1 mg, Dexamethasone 2 mg, and 0.9% NaCl 8 ml, was administered as a lymphotropic interstitial injection by puncturing the 10th cellular space of the femoral triangle of the lymphatic region. The injection was performed in each limb for 12 days.

[0107] Medicinal composition B was used: Neuromidin 15 mg, 1 ml, and Novocaine 0.5%, 2 ml. Treatment was performed by interstitial puncture of LT17 by inserting a needle into the interspinous space within L5-L6, puncturing the supraspinous ligament, and then administering the medicinal mixture. The course of treatment with medicinal composition B was 12 days. No side effects were observed.

[0108] Medicinal composition B, containing Longidaza 1000 IU and 4 ml of 0.5% Novocaine, was used. Treatment was performed by interstitial puncture (LT10), which involves inserting a needle into the interstitial space of the femoral triangle of the limb affected by edema, followed by administration of the medicinal mixture. The course of treatment with medicinal composition B lasted 3 days, with administration occurring on days 3, 7, and 10. No side effects were observed.

[0109] Compression hosiery was not used during the treatment.

[0110] The therapeutic effect was evident from the first day of treatment in the form of reduced swelling, a feeling of lightness in the legs, freer movement of the limbs, and a significant reduction in pain.

[0111] The results of the treatment course showed a significant decrease in the circumference of the limbs in different areas, ranging from 1.2 to 8 cm: in the upper third of the shin from 49.3 to 42.8 cm; in the lower third of the shin from 41.2 to 33.3 cm; foot circumference from 25 to 22 cm.

[0112] Ultrasound morphometry of the skin and subcutaneous tissue revealed a reduction in dermal thickness of up to 3 mm. Advantages of using the invention:

[0113] 1. Reduction of limb circumference to normal size without the use of compression hosiery during treatment. 2. Reduction or elimination of pain and other symptoms of neuropathy, restoration of range of motion in the limbs.

[0114] 3. Use of official medicines.

[0115] 4. Applicability to lymphedema of any etiology and stage.

[0116] 5. Use as a pathogenetic (primary) method of treating lymphedema.

Claims

CLAUSES OF THE INVENTION 1. A method for lymphotropic treatment of lymphedema, which involves sequentially preparing an injectable medicinal composition A containing a drug from the alpha-adrenergic agonist class and a glucocorticosteroid drug, performing a lymphotropic interstitial injection of the prepared medicinal composition A by puncturing the interstitium of the lymphatic region in question and administering medicinal composition A, preparing a medicinal composition B containing a cholinesterase inhibitor, performing a lymphotropic interstitial injection of medicinal composition B by puncturing the interstitium of the lymphatic region in question and administering medicinal composition B, wherein medicinal composition A is administered using a syringe dispenser for 30-40 minutes, medicinal composition B is administered manually, with a needle of a maximum size of 0.5*25 mm 25 G for 2-5 minutes, injections are performed once a day daily, for a course of 9-18 days.

2. The method according to paragraph 1, wherein, after completion of the administration of composition B, a medicinal composition C containing an enzyme is additionally prepared, a lymphotropic interstitial injection of medicinal composition C is carried out by puncturing the interstitium of the interested lymphatic region and introducing medicinal composition C, wherein the introduction of medicinal composition C is carried out manually, with a needle of a maximum size of 0.5*25 mm 25 G for 2-5 minutes, starting from the 3rd day of treatment and is performed a total of 3-5 times during the course of treatment.

3. The method according to claim 1, wherein the injectable medicinal composition A for the treatment of lymphedema, prepared ex tempore, contains a mixture of medicinal preparations including up to 2 mg of a drug of the Alpha-adrenergic agonist class, 2 mg of the drug Dexamethasone and up to 10 ml of a physiological solution of 0.9% NaCl.

4. The method according to any of paragraphs 1-3, wherein the injectable medicinal composition A as a drug from the Alpha-adrenergic agonist class contains a drug with the active substance phenylephrine.

5. The method according to any of paragraphs 1-3, wherein the injectable medicinal composition A as a drug from the Alpha-adrenergic agonist class contains a drug with the active substance midodrine.

6. The method according to claim 1, wherein the injectable medicinal composition B for the treatment of lymphedema, prepared ex tempore, contains a mixture of medicinal drugs, including up to 15 mg of a drug from the cholinesterase inhibitor group and up to 4 ml of anesthetic.

7. The method according to any of paragraphs 1, 6, wherein the injectable medicinal composition B, as a drug from the group of cholinesterase inhibitors, contains a drug with the active substance ipidacrine.

8. The method according to any of paragraphs 1, 6, wherein the injectable medicinal composition B as a drug from the anesthetic group contains a drug with the active substance lidocaine or procaine.

9. The method according to i.2, in which the injection medicinal composition B for the treatment of lymphedema, prepared ex tempore, contains a mixture of medicinal preparations that includes 1000 IU of a preparation from the enzyme group and up to 5 ml of an anesthetic, wherein the medicinal composition may contain a preparation with the active substance bovgiauloronidase azoximer as a preparation from the enzyme group, and the preparation from the anesthetic group may contain Lidocaine or procaine.

10. The method according to paragraph 1 or 2, in which, for the treatment of lymphedema of the upper extremities when administering medicinal composition A or B, a puncture of the interstitium of the lymphatic region LT 14 is performed by inserting a needle into the cellular space of the armpit on the side of the edema.

11. The method according to paragraph 1 or 2, wherein for the treatment of lymphedema of the lower extremities when administering medicinal composition A or B, the puncture of the interstitium of the lymphatic region LT 10 is performed by inserting a needle into the interstitium of the cellular space of the femoral triangle from the side of the edema.

12. The method according to paragraph 1 or 2, wherein for the treatment of lymphedema of the upper extremities when administering medicinal composition A or B, a puncture of the interstitium of the lymphatic region LT 15 is performed by inserting a needle into the interstitium of the cellular space of the lower third of the shoulder when the edema is localized only at the level of the forearm.

13. The method according to I.1, in which, for the treatment of lymphedema of the upper extremities, when administering medicinal composition B, a puncture of the interstitium of the lymphatic region LT 16 is performed by inserting a needle into the cellular space of the interspinous space within the boundaries of C6-C7 or C7-Th1.

14. The method according to item 1, in which for the treatment of lymphedema of the lower extremities, when administering the medicinal composition B, a puncture of the interstitium of the lymphatic region LT 17 is performed by inserting a needle into the cellular space of the interspinous space within the boundaries of L4-L5 or L5-S1.

15. The use of a medicinal composition A containing a drug from the alpha-adrenergic agonist class and a glucocorticosteroid drug for the lymphotropic treatment of lymphedema by puncture of the interstitium of the lymphatic region in question and administration of the medicinal composition A, wherein the medicinal composition A is a composition prepared ex tempore.

16. The use of medicinal composition B containing a cholinesterase inhibitor for lymphotropic treatment of lymphedema by puncturing the interstitium of the lymphatic region in question and administering medicinal composition B, wherein medicinal composition B is a composition prepared ex tempore.

17. Use of medicinal composition B containing an enzyme for lymphotropic treatment of lymphedema by puncturing the interstitium of the lymphatic region in question and administering medicinal composition B, wherein medicinal composition B is a composition prepared ex tempore.

18. The use of medicinal composition A, prepared ex tempore and containing a drug from the alpha-adrenergic agonist class and a glucocorticosteroid drug, in combination with medicinal composition B, prepared ex tempore and containing a cholinesterase inhibitor, and, if necessary, medicinal composition C, prepared ex tempore and containing an enzyme, for the lymphotropic treatment of lymphedema by puncture of the interstitium of the lymphatic region in question and sequential administration of said medicinal composition A, medicinal composition B and medicinal composition C.

19. Use according to i.15 or i.18, where the medicinal composition A contains a mixture of medicinal preparations including up to 2 mg of an Alpha-adrenergic agonist, 2 mg of the drug Dexamethasone and up to 10 ml of a 0.9% NaCl physiological solution.

20. Use according to paragraph 15, 18 or 19, wherein medicinal composition A, as a drug from the Alpha-adrenergic agonist class, contains a drug with the active substance phenylephrine.

21. Use according to paragraph 15, 18 or 19, where the medicinal composition A is The drug from the Alpha-adrenergic agonist class contains a drug with the active ingredient midodrine.

22. Use according to i.16 or 18, where medicinal composition B additionally contains an anesthetic.

23. Use according to item 22, where medicinal composition B contains a mixture of medicinal preparations, including up to 15 mg of a drug from the cholinesterase inhibitor group and up to 4 ml of an anesthetic.

24. Use according to item 16, 18, 22 or 23, where medicinal composition B contains a drug with the active substance ipidacrine as a drug from the cholinesterase inhibitor group.

25. Use according to any of paragraphs. 22-24, wherein medicinal composition B as a drug from the anesthetic group contains a drug with the active substance lidocaine or procaine.

26. Use according to i.17 or 18, wherein the medicinal composition B additionally contains an anesthetic.

27. Use according to item 26, wherein medicinal composition B contains a mixture of medicinal preparations that includes 1000 IU of a preparation from the enzyme group and up to 5 ml of an anesthetic, wherein the medicinal composition may contain a preparation with the active substance bovgiauloronidase azoximer as a preparation from the enzyme group, and the preparation from the anesthetic group may contain Lidocaine or procaine.

28. The use of a medicinal composition A containing a drug from the alpha-adrenergic agonist class and a glucocorticosteroid drug in a method for the lymphotropic treatment of lymphedema by puncture of the interstitium of the lymphatic region in question and administration of the medicinal composition A, wherein the medicinal composition A is a composition prepared ex tempore.

29. The use of medicinal composition B containing a cholinesterase inhibitor in a method for the lymphotropic treatment of lymphedema by puncturing the interstitium of the lymphatic region in question and administering medicinal composition B, wherein medicinal composition B is a composition prepared ex tempore.

30. The use of medicinal composition B containing an enzyme in a method for the lymphotropic treatment of lymphedema by puncturing the interstitium of the lymphatic region in question and administering medicinal composition B, wherein medicinal composition B is a composition prepared ex tempore.

31. The use of medicinal composition A containing a drug from the alpha-adrenergic agonist class and a glucocorticosteroid drug in combination with medicinal composition B containing a cholinesterase inhibitor in a method for the lymphotropic treatment of lymphedema, which involves sequentially preparing said medicinal composition A, performing a lymphotropic interstitial injection of the prepared medicinal composition A by puncturing the interstitium of the lymphatic region in question and administering medicinal composition A, preparing said medicinal composition B, performing a lymphotropic interstitial injection of medicinal composition B by puncturing the interstitium of the lymphatic region in question and administering medicinal composition B, wherein medicinal composition A is administered using a syringe dispenser for 30-40 minutes., the introduction of medicinal composition B is carried out manually, with a needle with a maximum size of 0.5*25 mm 25 G for 2-5 minutes, injections are performed daily once a day, for a course of 9-18 days.

32. Use according to paragraph 31, wherein in the method of lymphotropic treatment of lymphedema, after completion of the administration of composition B, a medicinal composition C containing an enzyme is additionally prepared, a lymphotropic interstitial injection of medicinal composition C is carried out by puncturing the interstitium of the interested lymphatic region and introducing medicinal composition C, wherein the introduction of medicinal composition C is carried out manually, with a needle of a maximum size of 0.5*25 mm 25 G for 2-5 minutes, starting from the 3rd day of treatment and is performed a total of 3-5 times during the course of treatment.

33. A combination of medicinal composition A, prepared ex tempore and containing a drug from the alpha-adrenergic agonist class and a glucocorticosteroid drug, medicinal composition B, prepared ex tempore and containing a cholinesterase inhibitor, and, if necessary, medicinal composition C, prepared ex tempore and containing an enzyme, for use in the lymphotropic treatment of lymphedema by puncture of the interstitium of the lymphatic region in question and sequential administration of said medicinal composition A, medicinal composition B, and medicinal composition C.

34. The use of a medicinal composition A containing a drug from the alpha-adrenergic agonist class and a glucocorticosteroid drug for the production of a medicinal product for the lymphotropic treatment of lymphedema by puncturing the interstitium of the lymphatic region in question and administering the medicinal composition A, wherein the medicinal composition A is a composition prepared ex tempore.

35. Use of medicinal composition B containing a cholinesterase inhibitor for the production of a medicinal product for the lymphotropic treatment of lymphedema by puncturing the interstitium of the lymphatic region in question and administering medicinal composition B, wherein medicinal composition B is a composition prepared ex tempore.

36. Use of medicinal composition B containing an enzyme for the production of a medicinal product for the lymphotropic treatment of lymphedema by puncturing the interstitium of the lymphatic region in question and administering medicinal composition B, wherein medicinal composition B is a composition prepared ex tempore.